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CompletedPhase 2Results posted

A Study of LY3437943 in Participants Who Have Obesity or Are Overweight

A Phase 2 Study of Once-Weekly LY3437943 Compared With Placebo in Participants Who Have Obesity or Are Overweight With Weight-Related Comorbidities

Asset

Retatrutide

Subcutaneous · GLP-1 / GIP / glucagon triple

Listed sites

28

Recruiting sites

Enrollment

338

actual

Study population

Obesity / overweight

Key I/E criterion

BMI 30-50

Primary endpoint

Body weight, % change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04881760
Org study ID18122
Secondary IDJ1I-MC-GZBFEli Lilly and Company

Timeline

Milestones

Study first posted2021-05-11actual
Study start2021-05-20actual
Primary completion2022-05-16actual
Study completion2022-11-22actual
Last update posted2023-09-13actual
Results first posted2023-09-13actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

Participants must have a Body Mass Index (BMI) ) ≥30 and ≤50 kilograms per square meter (kg/m²), or ≥27 kg/m² and <30 kg/m², with at least one of the following comorbidities: hypertension, dyslipidemia, cardiovascular disease
Participants must be willing to learn how to self-inject study drug or receive an injection from a trained individual if visually impaired or with physical limitations, and follow study procedures for the duration of the study, including, but not limited to, follow lifestyle advice (for example, dietary changes and physical activity plan), maintain a study drug administration log, and complete required questionnaires

Exclusion criteria

Participants must not have type 1 or type 2 diabetes mellitus
Participants must not have had an increase or decrease in body weight > more than 5 kg (11 pounds) within the past 3 months
Participants must not have had surgery for obesity or plan to have such surgery during the study
Participants must not be using medications that promote weight loss or cause weight gain
Participants must not drink excessive amounts of alcohol (more than 14 units a week for women or more than 21 units a week for men)
Participants must not have used marijuana within the last 3 months.
Participants must not have heart attack, stroke, or hospitalization for congestive heart failure in the past 3 months
Participants must not have active cancer within the last 5 years
Participants must not have uncontrolled high blood pressure
Participants must not have liver disease other than non-alcoholic fatty liver disease
Participants must not have renal impairment with estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m2
Participants must not have a history of acute or chronic pancreatitis symptomatic gallbladder disease or documented human immunodeficiency virus infection
Participants must not have a major problem with depression or other mental illness within the last 2 years
Participants must not have family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma (family is defined as a first degree relative)
Female participants must not be pregnant, breast-feeding, or intend to become pregnant or of childbearing potential and not using adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice)

Endpoints (28)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Weight & body composition

28 endpoints
Primary/registry result

Mean Percent Change From Baseline in Body Weight

Time frame:Baseline, Week 24

Body weight, % change

percent change from baseline, improvement

Posted result

GroupValue (least_squares_mean), percent change95% CI
Placebo-1.55
1 mg LY3437943-7.18
4 mg LY3437943 (2 mg)-12.00
4 mg LY3437943-13.80
8 mg LY3437943 (2 mg)-16.64
8 mg LY3437943 (4 mg)-18.26
12 mg LY3437943 (2 mg)-17.39
LS Mean difference (Final Values)-5.6495% CI-7.34-3.94p<0.001Mixed Models Analysis
LS Mean difference (Final Values)-10.4595% CI-12.21-8.70p<0.001Mixed Models Analysis
LS Mean difference (Final Values)-12.2595% CI-14.42-10.08p<0.001Mixed Models Analysis
LS Mean difference (Final Values)-15.1095% CI-16.90-13.30p<0.001Mixed Models Analysis
LS Mean difference (Final Values)-16.7295% CI-18.86-14.58p<0.001Mixed Models Analysis
LS Mean difference (Final Values)-15.8595% CI-17.57-14.13p<0.001Mixed Models Analysis
Primary/protocol endpoint

Mean Percent Change From Baseline in Body Weight

Time frame:Baseline, Week 24

Body weight, % change

percent change from baseline, improvement

Secondary/registry result

Mean Percent Change From Baseline in Body Weight

Time frame:Baseline, Week 48

Body weight, % change

percent change from baseline, improvement

Posted result

GroupValue (least_squares_mean), percent change95% CI
Placebo-2.11
1 mg LY3437943-8.67
4 mg LY3437943 (2 mg)-16.32
4 mg LY3437943-17.83
8 mg LY3437943 (2 mg)-21.72
8 mg LY3437943 (4 mg)-23.88
12 mg LY3437943 (2 mg)-24.22
LS Mean difference (Final Values)-6.5795% CI-8.94-4.20p<0.001Mixed Models Analysis
LS Mean difference (Final Values)-14.2195% CI-17.64-10.78p<0.001Mixed Models Analysis
LS Mean difference (Final Values)-15.7295% CI-19.05-12.40p<0.001Mixed Models Analysis
LS Mean difference (Final Values)-19.6295% CI-22.73-16.51p<0.001Mixed Models Analysis
LS Mean difference (Final Values)-21.7895% CI-25.05-18.51p<0.001Mixed Models Analysis
LS Mean difference (Final Values)-22.1195% CI-24.92-19.31p<0.001Mixed Models Analysis
Secondary/registry result

Percentage of Participants Who Achieve ≥ 5% Body Weight Reduction

Time frame:Week 24

≥5% weight-loss responders

threshold achievement, improvement

Posted result

GroupValue (number), percentage of participants95% CI
Placebo26
1 mg LY343794359
4 mg LY3437943 (2 mg)87
4 mg LY343794394
8 mg LY3437943 (2 mg)100
8 mg LY3437943 (4 mg)100
12 mg LY3437943 (2 mg)97
Risk Difference (RD)3395% CI1749p<0.001Regression, Logistic
Risk Difference (RD)6195% CI4577p<0.001Regression, Logistic
Risk Difference (RD)6895% CI5481p<0.001Regression, Logistic
Risk Difference (RD)7495% CI6385p<0.001Regression, Logistic
Risk Difference (RD)7495% CI6385p<0.001Regression, Logistic
Risk Difference (RD)7195% CI5982p<0.001Regression, Logistic
Secondary/registry result

Percentage of Participants Who Achieve ≥ 5% Body Weight Reduction

Time frame:Week 48

≥5% weight-loss responders

threshold achievement, improvement

Posted result

GroupValue (number), percentage of participants95% CI
Placebo27
1 mg LY343794364
4 mg LY3437943 (2 mg)87
4 mg LY343794397
8 mg LY3437943 (2 mg)100
8 mg LY3437943 (4 mg)100
12 mg LY3437943 (2 mg)100
Risk Difference (RD)3795% CI2054p<0.001Regression, Logistic
Risk Difference (RD)6095% CI4476p<0.001Regression, Logistic
Risk Difference (RD)7095% CI5783p<0.001Regression, Logistic
Risk Difference (RD)7395% CI6284p<0.001Regression, Logistic
Risk Difference (RD)7395% CI6284p<0.001Regression, Logistic
Risk Difference (RD)7395% CI6784p<0.001Regression, Logistic
Secondary/registry result

Percentage of Participants Who Achieve ≥ 10% Body Weight Reduction

Time frame:Week 24

≥10% weight-loss responders

threshold achievement, improvement

Posted result

GroupValue (number), percentage of participants95% CI
Placebo3
1 mg LY343794325
4 mg LY3437943 (2 mg)59
4 mg LY343794372
8 mg LY3437943 (2 mg)83
8 mg LY3437943 (4 mg)94
12 mg LY3437943 (2 mg)90
Risk Difference (RD)2295% CI1133p<0.001Regression, Logistic
Risk Difference (RD)5695% CI3873p<0.001Regression, Logistic
Risk Difference (RD)6995% CI5385p<0.001Regression, Logistic
Risk Difference (RD)8095% CI6693p<0.001Regression, Logistic
Risk Difference (RD)9195% CI83100p<0.001Regression, Logistic
Risk Difference (RD)8795% CI7896p<0.001Regression, Logistic
Secondary/registry result

Percentage of Participants Who Achieve ≥ 10% Body Weight Reduction

Time frame:Week 48

≥10% weight-loss responders

threshold achievement, improvement

Posted result

GroupValue (number), percentage of participants95% CI
Placebo9
1 mg LY343794327
4 mg LY3437943 (2 mg)73
4 mg LY343794376
8 mg LY3437943 (2 mg)90
8 mg LY3437943 (4 mg)91
12 mg LY3437943 (2 mg)93
Risk Difference (RD)1895% CI531p0.008Regression, Logistic
Risk Difference (RD)6495% CI4881p<0.001Regression, Logistic
Risk Difference (RD)6795% CI5184p<0.001Regression, Logistic
Risk Difference (RD)8195% CI6994p<0.001Regression, Logistic
Risk Difference (RD)8295% CI7194p<0.001Regression, Logistic
Risk Difference (RD)8495% CI7494p<0.001Regression, Logistic
Secondary/registry result

Percentage of Participants Who Achieve ≥ 15% Body Weight Reduction

Time frame:Week 24

≥15% weight-loss responders

threshold achievement, improvement

Posted result

GroupValue (number), percentage of participants95% CI
Placebo1
1 mg LY343794310
4 mg LY3437943 (2 mg)29
4 mg LY343794344
8 mg LY3437943 (2 mg)51
8 mg LY3437943 (4 mg)68
12 mg LY3437943 (2 mg)70
Risk Difference (RD)995% CI117p0.029Regression, Logistic
Risk Difference (RD)2795% CI1143p<0.001Regression, Logistic
Risk Difference (RD)4395% CI2660p<0.001Regression, Logistic
Risk Difference (RD)4995% CI3366p<0.001Regression, Logistic
Risk Difference (RD)6795% CI5183p<0.001Regression, Logistic
Risk Difference (RD)6895% CI5680p<0.001Regression, Logistic
Secondary/registry result

Percentage of Participants Who Achieve ≥ 15% Body Weight Reduction

Time frame:Week 48

≥15% weight-loss responders

threshold achievement, improvement

Posted result

GroupValue (number), percentage of participants95% CI
Placebo2
1 mg LY343794316
4 mg LY3437943 (2 mg)55
4 mg LY343794364
8 mg LY3437943 (2 mg)73
8 mg LY3437943 (4 mg)77
12 mg LY3437943 (2 mg)83
Risk Difference (RD)1595% CI624p0.002Regression, Logistic
Risk Difference (RD)5395% CI3670p<0.001Regression, Logistic
Risk Difference (RD)6395% CI4779p<0.001Regression, Logistic
Risk Difference (RD)7195% CI5587p<0.001Regression, Logistic
Risk Difference (RD)7595% CI6289p<0.001Regression, Logistic
Risk Difference (RD)8295% CI7192p<0.001Regression, Logistic
Secondary/registry result

Mean Change From Baseline in Body Weight

Time frame:Baseline, Week 24

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), kilograms (kg)95% CI
Placebo-1.27
1 mg LY3437943-7.72
4 mg LY3437943 (2 mg)-12.59
4 mg LY3437943-14.79
8 mg LY3437943 (2 mg)-17.70
8 mg LY3437943 (4 mg)-19.75
12 mg LY3437943 (2 mg)-18.53
LS Mean difference (Final Values)-6.4695% CI-8.36-4.56p<0.001Mixed Models Analysis
LS Mean difference (Final Values)-11.3295% CI-13.34-9.30p<0.001Mixed Models Analysis
LS Mean difference (Final Values)-13.5295% CI-15.99-11.05p<0.001Mixed Models Analysis
LS Mean difference (Final Values)-16.4395% CI-18.41-14.45p<0.001Mixed Models Analysis
LS Mean difference (Final Values)-18.4895% CI-20.93-16.04p<0.001Mixed Models Analysis
LS Mean difference (Final Values)-17.2695% CI-19.11-15.40p<0.001Mixed Models Analysis
Secondary/registry result

Mean Change From Baseline in Body Weight

Time frame:Baseline, Week 48

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), kg95% CI
Placebo-1.84
1 mg LY3437943-9.37
4 mg LY3437943 (2 mg)-17.32
4 mg LY3437943-19.13
8 mg LY3437943 (2 mg)-23.52
8 mg LY3437943 (4 mg)-25.88
12 mg LY3437943 (2 mg)-26.17
LS Mean difference (Final Values)-7.5395% CI-10.18-4.88p<0.001Mixed Models Analysis
LS Mean difference (Final Values)-15.4895% CI-19.35-11.60p<0.001Mixed Models Analysis
LS Mean difference (Final Values)-17.2995% CI-21.19-13.39p<0.001Mixed Models Analysis
LS Mean difference (Final Values)-21.6995% CI-25.25-18.12p<0.001Mixed Models Analysis
LS Mean difference (Final Values)-24.0495% CI-27.72-20.36p<0.001Mixed Models Analysis
LS Mean difference (Final Values)-24.3495% CI-27.40-21.27p<0.001Mixed Models Analysis
Secondary/registry result

Mean Change From Baseline in BMI

Time frame:Baseline, Week 24

BMI, change

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), kg/m^295% CI
Placebo-0.49
1 mg LY3437943-2.64
4 mg LY3437943 (2 mg)-4.47
4 mg LY3437943-5.13
8 mg LY3437943 (2 mg)-6.15
8 mg LY3437943 (4 mg)-6.84
12 mg LY3437943 (2 mg)-6.44
LS Mean difference (Final Values)-2.1595% CI-2.80-1.50p<0.001Mixed Models Analysis
LS Mean difference (Final Values)-3.9895% CI-4.66-3.29p<0.001Mixed Models Analysis
LS Mean difference (Final Values)-4.6495% CI-5.46-3.82p<0.001Mixed Models Analysis
LS Mean difference (Final Values)-5.6695% CI-6.34-4.99p<0.001Mixed Models Analysis
LS Mean difference (Final Values)-6.3595% CI-7.17-5.53p<0.001Mixed Models Analysis
LS Mean difference (Final Values)-5.9595% CI-6.59-5.32p<0.001Mixed Models Analysis
Secondary/registry result

Mean Change From Baseline in BMI

Time frame:Baseline, Week 48

BMI, change

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), kg/m^295% CI
Placebo-0.72
1 mg LY3437943-3.22
4 mg LY3437943 (2 mg)-6.14
4 mg LY3437943-6.67
8 mg LY3437943 (2 mg)-8.12
8 mg LY3437943 (4 mg)-9.02
12 mg LY3437943 (2 mg)-9.14
LS Mean difference (Final Values)-2.5095% CI-3.42-1.57p<0.001Mixed Models Analysis
LS Mean difference (Final Values)-5.4295% CI-6.81-4.03p<0.001Mixed Models Analysis
LS Mean difference (Final Values)-5.9595% CI-7.23-4.67p<0.001Mixed Models Analysis
LS Mean difference (Final Values)-7.4095% CI-8.62-6.18p<0.001Mixed Models Analysis
LS Mean difference (Final Values)-8.3095% CI-9.55-7.05p<0.001Mixed Models Analysis
LS Mean difference (Final Values)-8.4295% CI-9.49-7.35p<0.001Mixed Models Analysis
Secondary/registry result

Mean Change From Baseline in Waist Circumference

Time frame:Baseline, Week 24

Waist circumference, change

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), centimeters (cm)95% CI
Placebo-2.60
1 mg LY3437943-5.43
4 mg LY3437943 (2 mg)-10.33
4 mg LY3437943-12.55
8 mg LY3437943 (2 mg)-13.74
8 mg LY3437943 (4 mg)-14.99
12 mg LY3437943 (2 mg)-14.33
LS Mean difference (Final Values)-2.8295% CI-5.23-0.41p0.022Mixed Models Analysis
LS Mean difference (Final Values)-7.7395% CI-10.32-5.13p<0.001Mixed Models Analysis
LS Mean difference (Final Values)-9.9595% CI-12.47-7.43p<0.001Mixed Models Analysis
LS Mean difference (Final Values)-11.1495% CI-13.72-8.56p<0.001Mixed Models Analysis
LS Mean difference (Final Values)-12.3895% CI-14.87-9.90p<0.001Mixed Models Analysis
LS Mean difference (Final Values)-11.7395% CI-14.04-9.43p<0.001Mixed Models Analysis
Secondary/registry result

Mean Change From Baseline in Waist Circumference

Time frame:Baseline, Week 48

Waist circumference, change

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), cm95% CI
Placebo-2.64
1 mg LY3437943-6.49
4 mg LY3437943 (2 mg)-14.58
4 mg LY3437943-14.87
8 mg LY3437943 (2 mg)-18.53
8 mg LY3437943 (4 mg)-18.50
12 mg LY3437943 (2 mg)-19.60
LS Mean difference (Final Values)-3.8495% CI-6.77-0.91p0.010Mixed Models Analysis
LS Mean difference (Final Values)-11.9495% CI-15.54-8.33p<0.001Mixed Models Analysis
LS Mean difference (Final Values)-12.2295% CI-16.11-8.33p<0.001Mixed Models Analysis
LS Mean difference (Final Values)-15.8895% CI-19.33-12.43p<0.001Mixed Models Analysis
LS Mean difference (Final Values)-15.8595% CI-19.39-12.31p<0.001Mixed Models Analysis
LS Mean difference (Final Values)-16.9595% CI-20.13-13.78p<0.001Mixed Models Analysis
Secondary/protocol endpoint

Mean Percent Change From Baseline in Body Weight

Time frame:Baseline, Week 48

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieve ≥ 5% Body Weight Reduction

Time frame:Week 24

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieve ≥ 5% Body Weight Reduction

Time frame:Week 48

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieve ≥ 10% Body Weight Reduction

Time frame:Week 24

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieve ≥ 10% Body Weight Reduction

Time frame:Week 48

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieve ≥ 15% Body Weight Reduction

Time frame:Week 24

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieve ≥ 15% Body Weight Reduction

Time frame:Week 48

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Mean Change From Baseline in Body Weight

Time frame:Baseline, Week 24

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Mean Change From Baseline in Body Weight

Time frame:Baseline, Week 48

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Mean Change From Baseline in BMI

Time frame:Baseline, Week 24

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Mean Change From Baseline in BMI

Time frame:Baseline, Week 48

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Mean Change From Baseline in Waist Circumference

Time frame:Baseline, Week 24

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Mean Change From Baseline in Waist Circumference

Time frame:Baseline, Week 48

Waist circumference, change

change from baseline, improvement

Publications (5)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.